Sterile cap for a freeze-drying container and method of freeze-drying materials under sterile conditions



y 8, 1959 .c. E. BENDER ET AL 3,454,178

STERILE CAP FOR A FREEZE-DRYING CONTAINER AND METHOD OF FREEZE-DRYINGMATERIALS UNDER STERILE CONDITIONS Filed Jan. 1 0, 1966 V IN V EN TOR.(HA/u 5 E. 5540511 MA/erI/v c. PARK/N50!!! United States Patent3,454,178 STERILE CAP FOR A FREEZE-DRYING CON- TAINER AND '"METHOD OFFREEZE-DRYING MATERIALS UNDER STERILE CONDITIONS Charles E. Bender, 61Millrock Road, New Paltz, N.Y. 12561, and Martin C. Parkinson, MapleHouse, Beacon, N.Y. 12508 Filed Jan. 10, 1966, Ser. No. 529,598 Int. Cl.B65a 51/00, 51/08, 51/14 U.S. Cl. 215-37 ABSTRACT OF THE DISCLOSURE Acap and stopper assembly to maintain a sterile condition in a containerduring freeze-drying and stoppering.

This invention relates to a sterile cap for a freeze-drying containerand a method of freeze-drying materials under sterile conditions.

The freeze-drying technique has been applied successfully to thefreeze-drying of various biological materials such as, for example,vaccines and the like.

In freeze-drying material of this nature it is, of course, necessary toconduct the process under sterile conditions. If foreign bacteria shouldenter the container and contaminate the product the biologicalconsequences would be, of course, extremely serious. The freeze-driedvaccines and the like are injected into a patients body under sterileconditions.

Prior to the instant invention it was a rather diflicult procedure tofreeze-dry such materials under sterile conditions. The freeze-dryingprocess had to be carried out in a completely sterile room. Suchconditions are diflicult to maintain. Furthermore the packaging of thematerial also had to be carried out in such a completely sterile room.As a result, while it was heretofore successfully possible to conductfreeze-drying of biological materials under such sterile conditions thetechniques involved were costly, time consuming, and expensive.

Peculiarly, in contamination of products, bacteria do not contaminateunless they fall directly into the product. Bacteria are, of course,principally airborne. Hence, unless there are foreign conditionsagitating the air, such as wind or the like, bacteria will notcontaminate a container if the top of the container is covered.

The instant invention involves a structure which permits freeze-dryingof biological material under conditions wherein total sterility of theroom need not be obtained. The invention involves both the method ofcarrying out such process and apparatus for accomplishing the same.

The above constitutes a brief description of the instant invention andsome of the objects and advantages thereof. Other objects and advantagesof this invention will become apparent to the reader of thisspecification as the description proceeds.

The invention will now be described by reference to the accompanyingdrawings which are made a part of this specification.

FIG. 1 is a perspective view showing a container which is utilized forthe freeze-drying of biological material. The closure means which areused to maintain sterility after the container is capped are shown inthe partially open position that said means assume while freeze-dryingis taking place.

FIG. 2 is a view similar to that of FIG. 1 but showing the closure meansclosing the mouth of the container and with the cap portion crimped overthe container so that sterility is maintained until the material is tobe used.

FIG. 3 is a cross-sectional view taken along lines 33 of FIG. 1.

1 Claim ice The invention will now befurther described by reference tothe specific form thereof shown in the accompanying drawings. In thisconnection, however, the reader is cautionedto notethat thespecific formof this invention as set forth in the instant specification is forillustrative purposes and for purposes of example only. Various changesand modifications may obviously be made within the spirit and scope ofthis invention and would occur to those skilled in this art.

Now referring to the specific form of the instant in vention as setforth in the drawings a freeze-drying container assembly 11 comprises areceptacle portion 12 which is provided with a circular mouth 13thereupon and a circumferential outwardly extending flange 14 carried bythe mouth. A resilient stopper 15 is selectively disposable within mouth13 of portion 12 either in stoppered (FIG. 2) relationship or partiallystoppered (FIG. 1) relationship. A plurality of longitudinal grooves 16and 17 are provided within stopper 15'. Stopper 15 includes an outwardlyand upwardly tapered body portion 18 having a smallest diameter 19 and alargest diameter 20. The smallest diameter 19' is no greater than thediameter of mouth 13- and the greatest diameter is greater than thediameter of mouth 13. Thus the body portion of stopper 15 can firmlyclose the mouth of the container.

A holding portion 22 is provided on stopper 15 which is carried by thebody portion thereof and is adapted to overlie mouth 13 of receptacleportion 12.

A cap 23 is provided with an interior perimetral recess 24 within whichholding portion 22 of stopper 15 is supported. Cap 23 is also formedwith a perimetrally disposed downwardly depending portion 25 which isadapted to overlie and embrace mouth 13 of receptacle 12. Downwardlydepending portion 25 is also adapted to be crimped under flange 14 asshown in FIG. 2.

With the foregoing specific description the operation of this inventionmay now be explained.

Biological material 30 is placed within receptacle 12 under sterileconditions. The stopper is placed within the mouth of the freeze-dryingreceptacle in the position shown in FIG. 1 and the device is attached toa freeze-drying apparatus of conventional type. At this point sterileconditions need no longer be maintained since the cap portion of thestopper overlies the container and prevents further contamination. Thefreeze-drying process is now continued until the biological materialwithin the container is freeze-dried. At that point the stopper isplaced in the position shown in FIG. 2, the cap is crimped beneath theflange, and the container may then be sold. Sterile conditions will bemaintained until the biological material within the container isactually used.

The foregoing sets forth the manner in which the objects of thisinvention are achieved.

We claim:

1. A sterile closure arrangement particularly adapted for use inmaintaining sterility of a container contents during freeze-dryingthereof, said closure arrangement comprising a resilient stopper havinga tapered body portion adapted for selective disposition in the mouth ofa container, said body portion having a diametrically disposed slotextending axially of said body portion and being operative to permitcommunication with the interior of the container when said stopper ispartially inserted in the mouth thereof, said stopper including a flangeof greater diameter than said body portion and adapted to overlie themouth of said container to assist in sealing said container when saidbody portion is completely inserted in said mouth, and a sterile capcovering said flange on said body portion, said sterile cap including atop and a perimetrically disposed, downwardly depending skirt, and meansin said cap to-embrace and retain said flange on said body portion toprovide a sterile shield 3 4 during freeze-drying of the contents andstoppering of 2,927,709 3/ 1960 Hoflman et a1. 215-47 said container.

References Cited JOSEPH R. LECLAIR, Primary Examiner. UNITED STATESPATENTS CL 2,734,649 2/1956 Callahan et a1. 215-37 5 21548 2,792,6785/1957 Baldwin et a1. 53101

